Cortizone 10 Cooling Gel

Cortizone 10 Cooling Gel
SPL v4
SPL
SPL Set ID 14d9fce2-9f54-4204-83cb-161de8a303f0
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Alcohol Aloe Vera Leaf Oat Dimethicone Edetate Disodium Anhydrous Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Isohexadecane Maltodextrin Menthyl Lactate, (-)- Methyl Gluceth-20 Methylparaben Polysorbate 60 Ppg-3 Benzyl Ether Myristate Propylparaben Sodium Citrate, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Cortizone 10 Cooling Gel Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone 10 Cooling Gel Drug Facts

In

alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:  

     eczema  psoriasis    poison ivy, oak, sumac    insect bites  detergents  jewelry    cosmetics

      soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

 other uses of this product should only be under the advice and supervision of a doctor

Section 42229-5

Cortizone 10

Cooling Gel

Drug Facts

Warnings

For external use only

Directions

■ for itching of skin irritation, inflammation, and rashes:  

      ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

       children under 2 years of age: ask a doctor

  for external anal and genital itching, adults:

       when practical, clean the affected area with mild soap and warm water and rinse thoroughly

       gently dry by patting or blotting with toilet tissue or a soft cloth before applying

      ■ apply to affected area not more than 3 to 4 times daily

      ■ children under 12 years of age: ask a doctor

Do Not Use

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Principal Display Panel

MA X IMUM STRENGTH

Cortizone 10


COOLING

ITCH RELIEF GEL


1% Hydrocortisone


Anti-Itch Gel

Net wt 1 oz (28 g)

When Using This Product

avoid contact with eyes  ■ do not use more than directed unless told to do so by a doctor  do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

In

alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:  

     eczema  psoriasis    poison ivy, oak, sumac    insect bites  detergents  jewelry    cosmetics

      soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

 other uses of this product should only be under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Cortizone 10

Cooling Gel

Drug Facts

Purpose

Anti-itch

Warnings

For external use only

Directions

■ for itching of skin irritation, inflammation, and rashes:  

      ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

       children under 2 years of age: ask a doctor

  for external anal and genital itching, adults:

       when practical, clean the affected area with mild soap and warm water and rinse thoroughly

       gently dry by patting or blotting with toilet tissue or a soft cloth before applying

      ■ apply to affected area not more than 3 to 4 times daily

      ■ children under 12 years of age: ask a doctor

Do Not Use (Do not use)

■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MA X IMUM STRENGTH

Cortizone 10


COOLING

ITCH RELIEF GEL


1% Hydrocortisone


Anti-Itch Gel

Net wt 1 oz (28 g)

When Using This Product (When using this product)

avoid contact with eyes  ■ do not use more than directed unless told to do so by a doctor  do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

■ rectal bleeding occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)